Kornimate/medical-research-clean huggingface dataset:
nattokinase supplementation and hemostatic factors

Conditions: Hypercholesterolemia

Summary: the aim of this study is to examine the effects of nattokinase supplementation on hemostatic factors in nondiabetic and hypercholesterolemic subjects. collagen-epinephrine closure time, prothrombin time, activated partial thromboplastin time, fibrinogen levels, and lipid profiles were measured at baseline and at 8-week follow-up.


Eligibility criteria:
inclusion criteria: * age between 20 and 69 years * hypercholesterolemia (200mg/dl ≤ serum cholesterol ≤ 280mg/dl) * nondiabetic (fasting blood glucose \< 126mg/dl and 2-hour blood glucose \< 200mg/dl) exclusion criteria: * use of any medication or supplements * diagnosis of dyslipidemia, diabetes mellitus, hypertension, liver disease, renal disease, cardiovascular disease, pancreatitis, cancer, or any life-threatening illness that required regular medical treatment * women who were pregnant, breastfeeding or intending to become pregnant during the study period * drug or alcohol abuse
oklahoma native american women's osteoporosis screening study

Conditions: Osteoporosis

Summary: native american women may be considered high risk for osteoporosis due to lifestyle factors and incidence of type 2 diabetes. the objectives of this study are to: 1) determine the prevalence of osteopenia/osteoporosis in native american female volunteers; 2) to evaluate their rate of bone loss; 3) to assess the relationship between lifestyle factors, inflammatory mediators, and select endocrine parameters on osteoporosis risk; and 4) determine the barriers to treatment. participants will undergo a baseline, year 1 and year 2 follow-up osteoporosis risk assessment. data will be analyzed using repeated measures anova and logistical regression.

osteoporosis, characterized by decreased bone density and deterioration in bone microarchitecture, is estimated to afflict 1 out of 2 women over the age of 50 years. these estimates are based primarily on caucasian populations with limited information in native americans. native american women may be considered high risk for osteoporosis due to lifestyle factors in conjunction with the incidence of diabetes. the objectives of this study are to: 1) determine the prevalence of osteopenia/osteoporosis in native american female volunteers, aged 50+ years, who are eligible for health care through indian health services; 2) to evaluate their rate of bone loss, 3) to assess the relationship between lifestyle factors, inflammatory mediators, and select endocrine parameters on osteoporosis risk; and 4) determine the barriers to treatment. native american women aged, 50+ years, who are eligible for services through indian health services in the oklahoma city (okc) area will be recruited. participants will undergo a baseline osteoporosis risk assessment, i.e. medical history, dual-energy x-ray absorptiometry (dxa) scans, dietary and physical activity assessment, and optional blood draw, and then encouraged to return to their primary care physician for counsel and/or treatment. serum markers of bone metabolism, endocrine parameters (e.g. vitamin d metabolites) and inflammatory molecules will be assessed for participants that consent to the blood draw. all participants will receive educational information related to osteoporosis risk and prevention, and follow-up visits scheduled at the end of year 1 and year 2. data will be analyzed using repeated measures anova and logistical regression with the α set at 0.05 for statistical significance.

Eligibility criteria:
inclusion criteria: * native american women who are eligible fore services at indian health clinics in okc * 50 years of age or older exclusion criteria: * women who weigh more than 300 lbs or who are pregnant or cognitively impaired

Keywords: osteoporosis bone inflammation diabetes vitamin d
design of new personalized therapeutic approaches for diffuse large b-cell lymphoma

Conditions: Diffuse Large B Cell Lymphoma

Summary: in europe diffuse large b-cell lymphoma (dlbcl) is a rare disease whereas in italy it is not. approximately 40% of dlbcl patients has refractory disease or will relapse after initial response. in onco-hematology, a role for gut microbiota (gm) in mediating immune activation in response to chemotherapy, has been suggested. in this scenario, the investigators hypothesized that gm could play an important role in dlbcl prognosis and response to treatment, establishing a connection between lifestyle and clinical response. the project is aimed to the study of the functional gm layout in association with specific patterns of treatment response in de novo dlbcl undergoing standard first line chemo-immunotherapy. results may build the scientific basis to design new and personalized intervention strategies (both in treatment approach and in life-style recommendations), to enhance clinical response and reduction of disease refractoriness through modulation of the gut microbial ecosystem.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. patients affected by histologically confirmed diffuse large b-cell lymphoma 3. patients amenable for therapy with rchop (rchop is the standard first line therapy for dlbcl and it scheduled regardless of participation in present study). 4. patients must provide written informed consent. exclusion criteria: 1. concomitant second malignancy, other than lymphoma. 2. previous anti-lymphoma therapy. 3. pregnancy or breastfeeding. 4. evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.

Keywords: rchop first line microbiota response disease control therapy toxicity
clinical experimental study to investigate specific features of clampart®

Conditions: Diabetes Mellitus

Summary: a single centre, clinical experimental study. every subject will undergo clamp experiments, where a clamp device (clampart®) measures and controls the blood glucose concentration after administration of marketed insulin products.


Eligibility criteria:
inclusion criteria: * healthy, td1, td2 exclusion criteria: * participation in a trial within the last weeks
mitochondrial respiratory function in mammalian skeletal muscle

Conditions: Cancer; Cachexia

Summary: the purpose of this study is to determine whether skeletal muscle mitochondrial function is altered in patients with head and neck cancer compared to healthy controls.

20 men and women, 30-60 years, equally divided between patients diagnosed with advanced (stages iii or iv), persistent (recurrence within 6 months) or recurrent head and neck squamous cell carcinoma (hnscc) (n=10) and healthy age matched control subjects (n=10) will be studied. muscle biopsies will be collected from cancer patients before and after a 4 week standard of care (soc) treatment. muscle biopsies from healthy control subjects will be collected at baseline only. lean body mass and fat mass will be determined by a dexa scan before and after 4 week soc treatment (cancer patients) to document any change in body composition (cachexia), and at baseline only in the age-matched healthy controls. blood will be collected from both cancer patients and healthy subjects to examine hormone levels at the time of biopsy.

Eligibility criteria:
inclusion criteria: 1. men and women, aged 30-60 years. 2. diagnosed with advanced (stages iii or iv), persistent (recurrence within 6 months) or recurrent head and neck squamous cell carcinoma (hnscc) and being treated at utmb (n=10). 3. healthy sex and age matched controls (n=10.) 4. able to comprehend risks and sign a consent form. 5. fluent in english exclusion criteria: 1. significant renal or heart disease or any acute metabolic disease. 2. evidence of hepatitis as indicated by a 3-fold increase in of 2 out of 3 liver enzymes. 3. diabetes mellitus or other untreated endocrine disease. 4. recent (within 3 months) treatment with anabolic steroids. 5. ongoing anticoagulant therapy. 6. polycystic ovary syndrome (pcos) and/or hyperthecosis. 7. non-classical adrenal hyperplasia. 8. cushing's syndrome. 9. pregnancy. 10. hyperprolactinoma, hypothyroidism. 11. granulocyte count below 1.5x103/µl 12. platelet count below 150 x 103/µl 13. white blood cell count below 1.0x103/µl 14. hemoglobin below 8.0 g/dl 15. organ transplant, hiv, or other criteria deemed immunosuppressing by the pi or study physician. 16. any other circumstance deemed exclusionary by the pi or study physician.

Keywords: cancer cachexia
effort further extension study

Conditions: Hepatitis B, Chronic

Summary: the purpose of this study is to demonstrate that long-term treatment (up to six years) with telbivudine or telbivudine plus adefovir results in the regression in liver inflammation and fibrosis/cirrhosis.


Eligibility criteria:
inclusion criteria: 1. patients who completed effort extension study. 2. patients who had baseline (that is the week 0 of effort study) hbv dna \<9 log copies/ml and alt ≥2×uln. 3. patients who are willing to participate in the further extension study. 4. patient is willing and able to comply with the study drug regimen and all other study requirements. 5. patients must give written informed consent before any assessment is performed. exclusion criteria: 1. poor compliance judged by investigators

Keywords: chronic hepatitis b
the effect of different emergency medical systems on the prognosis of traumatic brain injury - a prospective study

Conditions: Traumatic Brain Injury

Summary: the aim of the study is to measure the effect of finnish physician-staffed ems unit treatment methods on traumatic brain injury (tbi) patient prognosis. physician-staffed hems unit was implemented to the ems 2011. the aim of this study is to compare the results against a historical database to see if the implementation of a hems unit will improve the prognosis of tbi patients.

a secondary aim is to identify out-of-hospital treatment factors that can be influenced by education and protocols.

Eligibility criteria:
inclusion criteria: * tbi with cgs \< 9 or unconsciousness verified by an on-call neurosurgeon during admission to the hospital. exclusion criteria: * multiple trauma

Keywords: traumatic brain injury hems out-of-hospital finland
the physiotherapy approaches in patients with subacromial impingement syndrome

Conditions: Subacromial Impingement Syndrome

Summary: the aim of this study is to investigate the effectiveness of electromyographic biofeedback with proprioception exercises on pain, range of motion, muscle strength, proprioception and functionality in patients with subacromial impingement syndrome.

this study is planned as a prospective, randomized clinical study. patients with subacromial impingement syndrome who volunteered to participate in the study, met the inclusion criteria, and signed the consent form were randomly assigned to the proprioception exercise group and the proprioception exercise with electromyographic biofeedback group. demographic and clinical data of the patients were recorded. shoulder function with disabilities of the arm, shoulder and hand scale, pain with vas, painless active shoulder flexion, abduction, and external-internal rotation with goniometer, muscle strength with manual muscle tester, proprioception (55°-90°- 125° angles of flexion and abduction, and angular deviations) with the laser-pointer assisted angle reproduction test were evaluated, and patient satisfaction was evaluated with the global rating of change scale. after the initial evaluations were completed, only proprioception exercises and proprioception exercises with emg-bf were applied 2 days a week for 8 weeks. additionally, both groups were given want exercises.

Eligibility criteria:
inclusion criteria: * being diagnosed with subacromial impingement syndrome, * being between the ages of 18 and 65, * not having received medical treatment, * not having received a shoulder-related physiotherapy program in the last year, * not having had any shoulder-related surgery, exclusion criteria: * neurological deficits of the upper extremity and the presence of another orthopedic disorder, rheumatic or congenital disease other than subacromial impingement syndrome, * presence of mental problem, * having received corticosteroid treatment in the last year, * upper extremity fracture, * acute cervical pathology, * having cardiovascular and systemic diseases that prevent working, * pregnancy, * those with communication problems.

Keywords: shoulder impingement syndrome shoulder pain proprioception biofeedback
effects of faradic current versus ankle-foot orthosis in patients with foot drop

Conditions: Foot Drop

Summary: this research aims to compare changes in gait quality and function between faradic current \& ankle foot orthosis with stroke related foot drop

randomized control trial study will be carried out at different health care units when synopsis will be approved. enrollment of patients will be done by using purposive sampling technique. the selection of the patients will be done on the basis of exclusion criteria and inclusion criteria. the patients enrolled will be divided into 2 groups. group a patients will be given faradic current on the other hand group b patients will be provided with ankle foot orthosis. the assessment of the patient will be done after 6 months and the outcome tools used will be 10-meter walk test, stroke impact scale, 6-meter walk test, berg balance scale, time up and go test. the data of the patient will be noted before giving treatment and after treatment and will be compared after 6 months. consent will be taken from each patient. statistical package of social sciences version 20 will be used for the entry and analysis of data

Eligibility criteria:
inclusion criteria: * patients who had been affected by stroke * good communication skills so the patient can follow the instructions * patients of both genders with any age group exclusion criteria: * impairment in lower limb other that foot drop * patient suffering with any cardiovascular disease

Keywords: stroke faradic current ankle-foot orthosis foot drop randomized control trial
vzv pcr sampling validation study

Conditions: Herpes Zoster

Summary: this study will evaluate and compare various methods for collecting lesion samples from subjects with clinically diagnosed herpes zoster for the laboratory confirmation of herpes zoster. the samples will be tested by polymerase chain reaction (pcr) to detect vzv dna. multiple samples from each type of herpes zoster lesion will be collected in order to determine whether the analysis of duplicate samples enhances the sensitivity of vzv dna detection for the diagnosis of herpes zoster. in addition, blood will be collected for the evaluation of vzv immunity at the time of the initial herpes zoster sample collection (after herpes zoster has been clinically diagnosed) and one month later in order to establish the range of cellular and humoral immune responses during natural herpes zoster in adults ≥50 years old.

this non-prophylactic, non-therapeutic study involves no treatment of study participants. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

Eligibility criteria:
inclusion criteria: * clinically diagnosed with herpes zoster by the investigator including the presence of a typical herpes zoster rash. * a male or female aged 50 years or older at the time of the subject's enrolment. * written informed consent obtained from the subject. * subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. exclusion criteria: * any malignancy for which the subject is receiving active treatment, or any haematological malignancy. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccination, including corticosteroids, except inhaled and topical steroids are allowed. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * previous vaccination against herpes zoster. * confirmed or suspected immunosuppression, based on medical history or physical examination (no laboratory testing required). * a family history of congenital or hereditary immunodeficiency. * history of or chronic alcohol or drug abuse.

Keywords: herpes zoster pcr varicella zoster virus (vzv) shingles gsk biologicals
powerlink bifurcated stent graft long-term follow-up study

Conditions: Abdominal Aortic Aneurysm

Summary: endologix infrarenal bifurcated stent graft study


Eligibility criteria:
inclusion criteria: * all surviving patients from the original study cohort who received the powerlink device * all surviving patients from the original study cohort who were assigned to the open surgical control arm

Keywords: evar aaa aneurysm powerlink
role of topical oxytocin gel in post-menopausal women

Conditions: Menopause Related Conditions

Summary: aim of the current study: to evaluate the effect of a14 day treatment period with local intravaginal application of an oxytocin-containing gel on vaginal atrophy, psychosexual and psychological/cognitive function, and metabolic, stress, and inflammatory parameters in egyptian post-menopausal women


Eligibility criteria:
inclusion criteria: * the women were post-menopausal and were between 47 and 67 years old * the women's last menstruation had occurred more than one year prior to the study * the women had an established vaginal atrophy * the women scored \< 26 in the female sexual function index (fsfi) * the women had an active sexual relationship exclusion criteria: * women who smoked * women who used hormone replacement therapy * women using a vaginal lubricant * women having any vaginal bleeding or any breast diseases * women having any undiagnosed genitalia disorder * women suffering from chronic diseases such as diabetes, hypertension, cardiovascular disease, or psychiatric disease
encorafenib, binimetinib and cetuximab in subjects with previously untreated braf-mutant colorectal cancer

Conditions: BRAF V600E-mutant Metastatic Colorectal Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of the combination of study drugs encorafenib, binimetinib and cetuximab in patients who have braf v600 mutant metastatic colorectal cancer and have not received any prior treatment for their metastatic disease.

the presence of a brafv600e mutation is considered a marker of poor prognosis in subjects with mcrc. the preclinical results and preliminary clinical data together justify the evaluation of this triple combination in the first-line setting of this population. the primary objective of the study is to evaluate the antitumor activity of the combination of encorafenib, binimetinib and cetuximab by assessing the overall response rate in adult subjects with previously untreated brafv600e-mutant metastatic colorectal cancer. it will also assess the effect of the triple combination on the duration of response, time to response, progression-free survival and overall survival and assess the effect on quality of life. it will also characterize the safety and tolerability of the triple combination as well as describe the pharmacokinetics (pk) of encorafenib, binimetinib, and cetuximab.

Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years of age * histologically or cytologically confirmed crc that is metastatic * presence of braf v600e in tumor tissue determined by local assay at any time prior to screening * evidence of measurable disease as per recist, v1.1 * subject able to receive cetuximab as per approved label with regards to ras status * eastern cooperative oncology group status (ecog) 0 or 1 * adequate renal, hepatic, cardiac and bone marrow functions and adequate electrolytes as per protocol * subject able to take oral medications exclusion criteria: * prior systemic therapy for metastatic disease * prior treatment with any raf inhibitor, mek inhibitor, cetuximab or other anti-egfr inhibitors * symptomatic brain metastasis or leptomeningeal disease * history or current evidence of retinal vein occlusion (rvo) or current risk factors for rvo * history of chronic inflammatory bowel disease or crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤ 12 months prior to first dose. * impaired cardiovascular function or clinically significant cardiovascular diseases: history of myocardial infarction or coronary disorders within 6 months prior to start of study treatment, symptomatic congestive heart failure (grade 2 or higher), past or current clinically significant arrhythmia and/or conduction disorder within 6 months prior to study treatment start * history of thromboembolic or cerebrovascular events within 6 months prior to start of study treatment * concurrent neuromuscular disorder that is associated with potential elevation of creatine kinase * known contraindication to cetuximab administration as per spc/approved label

Keywords: metastatic colorectal cancer